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Testing Times

Posted AtThe Times of India

Now that the government has announced
it will make it mandatory to register clinical trials,
India should be more open to an industry that can, by
2010, become as important as the BPO and information
technology sectors. Yet fears about rogue clinical trials
are justified.

Although the Streptokinnese case (eight deaths in experiments
without subjects' consent) is well remembered, it's
not the only instance of malpractice. In 2003, over
400 Women were administered Letrozole to study if it
induced ovulation, without their consent or knowledge.

Considering that such activities were deemed crimes
against humanity by the international tribunal in Nuremberg
in 1947, public outrage in India is understandable.

But the drug controller-general of India has announced
a transparent registry and safeguards system similar
to those in the US and UK, so it's time to snap out
of victim mode. Big companies like Novo Nordisk, Aventis,
Novartis, GlaxoSmithKline, Eli Lilly and Pfizer have
been testing drugs here, and not all chose India for
its lax regulatory system.

India has a huge multiracial, multi-ethnic gene pool,
and a high incidence of cancer, Diabetes, cardiovascular
diseases, Epilepsy, Alzheimer's and so on. Also, India
provides cheap labour and low running costs: There are
14,000 hospitals with 7,00,000 beds, over half a million
practising doctors, and 200 recognised colleges graduating
over 17,000 doctors each year. By conducting trials
in India, overseas drug companies can slash R&D costs
by 30 per cent to 50 per cent. So, clinical testing
can turn into the BPO story all over again. To get there
we need vigilant and scrupulous regulatory bodies and
mechanisms in place.

Indeed, the Confederation of Indian Industry (CII) reckons
revenues from this sector could touch $5 billion by
2010. It makes sense to make all trial data public because
of the inter-national attention and scrutiny.

The pharmaceutical industry earns two-thirds of its
profits in the US, and according to a Harris poll, Americans
were repelled by recent reports of unethical practices.

Moreover, the US FDA does not accept unethically obtained
clinical data. If procedures used in India were to be
made public, pharma companies would be too concerned
about possible international bad press and lawsuits
to try corrupt practices here

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